Dr Herrera on the Significance of the FDA Approval of Nivolumab Plus AVD for Classical Hodgkin Lymphoma

“The [FDA] approval for nivolumab plus AVD for patients with untreated, advanced-stage Hodgkin lymphoma marks an important advance for the treatment of these patients.”

Alex Herrera, MD, a professor and chief of the Division of Lymphoma in the Department of Hematology & Hematopoietic Cell Transplantation, as well as associate medical director of the Briskin Center for Clinical Research, at City of Hope, discussed the significance of the March 2026 FDA approval of nivolumab (Opdivo) in combination with doxorubicin, vinblastine, and dacarbazine (AVD) for patients with previously untreated stage III or IV classical Hodgkin lymphoma, its impact on the Hodgkin lymphoma treatment paradigm, and the data that supported the decision.

Herrera began by remarking that data for nivolumab plus AVD demonstrated sizable improvements in outcomes for patients compared with brentuximab vedotin (Adcetris) plus AVD. Moreover, he noted that in addition to improving outcomes for patients, nivolumab plus AVD was well tolerated.

The regulatory decision was based on data from the phase 3 CA209-8UT/SWOG 1826 study (NCT03907488), which showed median progression-free survival (PFS) outcomes in favor of patients in the nivolumab plus AVD arm (HR, 0.42; 95% CI, 0.27-0.67; P < .0001). Furthermore, 3-year follow-up data from the trial presented at the 2025 ASH Annual Meeting and Exposition displayed a 3-year PFS rate of 91% (95% CI, 88%-93%) in the nivolumab arm (n = 487) compared with 82% (95% CI, 78%-85%) in the brentuximab vedotin arm (n = 483; HR, 0.48; 95% CI, 0.34-0.69; P < .0001). Regarding safety, serious adverse effects (AE) and grade 3 or 4 immune-mediated AEs occurred at respective rates of 39% and 2.7% for patients in the nivolumab arm.

Herrera closed by underscoring how he believes that the promising data for the nivolumab-based combination positions it to be a new standard-of-care in the frontline setting for patients with advanced-stage classical Hodgkin lymphoma.